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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Catalog Number 130710000
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient received delta xtend shoulder prosthesis left side in 2016.Since about one year after implantation patient experienced pain.Revision because of pain on (b)(6) 2020.Intraoperatively patient tissue was found to be black.Surgeon is suspecting a low grade infection; there were no signs of metal wear that would have caused the black tissue.
 
Event Description
The patient was revised on (b)(6) 2020 to address "loosening of shoulder tep", with severe metallosis, pronounced chronic fibrosing and scarring inflammation with metallosis.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, a2 (birth date), b5, d2b, d4 (procode,lot,exp,udi), d6a, d9, d10, g5, h4 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate corrected: d1, d2, d3, g1, h3 and h6 (device).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Corrected: h3.
 
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Brand Name
DXTEND MODULAR HUM STEM D10 HA
Type of Device
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key10741779
MDR Text Key213248213
Report Number1818910-2020-23393
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
PMA/PMN Number
K021478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number130710000
Device Lot Number5304379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2020
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNK SHOULDER GLENOSPHERE DELTA XTEND; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNK SHOULDER HUMERAL STEM DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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